I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products, although I’ve personally inherited stock in Johnson & Johnson. My expertise is based on post-doc training in epidemiology and as a faculty member and researcher at Vassar, Yale, at Harvard. I’ve also worked at HHS, the U.S. Congress and White House.
We’ve heard today that the agencies are doing many things right, but the vaccine trials have serious design flaws. The standards set in FDA guidances and the study protocols make it likely that vaccines that will be authorized or approved won’t achieve what the public and policy makers expect. Instead, these vaccines will only be proven to reduce the risk of mild infections but not proven to reduce the risk of hospitalization, ICU use, or deaths.
The major flaws are as follows:
- The FDA’s proposed primary endpoint is defined as symptomatic Covid-19 that can include only 1 very mild symptom, such as a mild cough or sore throat – as long as the person has tested positive.
- FDA’s requirement of at least 2 months median follow-up after vaccination or placebo is too short to study efficacy. Even if a person is exposed during that time, we don’t know the correlates of protection and so we need a longer follow-up to know how long an effective vaccine remains effective. We can’t rely on post-market studies for that information, because once a vaccine is on the market, many people in the placebo control group will switch to a vaccine.
- We don’t know whether diversity of study participants will be achieved in terms of age, race, or co-morbidities, especially for people who are exposed to the virus.
- The requirement of at least 5 serious Covid-19 cases in the placebo group is completely inadequate for 2 reasons:
- Serious Covid-19 cases are too loosely defined, and could include a case of mild Covid-19 if the patient has a blood oxygen saturation under 93%. But thousands of otherwise healthy Americans have levels below that.
- Even if the definition were more stringent, such as requiring hospitalization or death, and even if there were no such cases among the vaccinated patients, the absolute difference in disease between 0 and 5 serious cases would not be clinically meaningful to individuals and could easily have occurred by chance.
The American public has been told for months that life can go back to normal when we have a vaccine. It isn’t FDA’s job to achieve that overly optimistic goal for any vaccine, but it is FDA’s job to make sure that a vaccine has meaningful benefits for the health and lives of most Americans, and especially those most at risk.